CONTRACT RESEARCH ORGANIZATIONS: AN

INDUSTRY ANALYSIS

Maysoun Dimachkie Masri, Sc.D, MBA, MPH

(Corresponding Author)

Assistant Professor, Department of Health Management and Informatics

College of Health and Public Affairs, University of Central Florida

HPA II, Suite 214

Orlando, FL 32816-2205

407-823-2359, 407-823-6138 (fax), E-mail: Maysoun.Dimachkie@ucf.edu

Bernardo Ramirez, PHD

Assistant Professor, Department of Health Management and Informatics

College of Health and Public Affairs, University of Central Florida

407-823-0245, E-mail: bramirez@mail.ucf.edu

Cristina Popescu, MA

Doctoral Student, Health Services Management and Research

College of Health and Public Affairs, University of Central Florida

352-317-6920, E-mail: cristina.popescu@knights.ucf.edu

Ed Michael Reggie, MBA

Chairman of the Board

GuideStar Clinical Trials Management

E-mail: emreggie@futurefactory.com
 CONTRACT RESEARCH ORGANIZATIONS: AN
INDUSTRY ANALYSIS
ABSTRACT

Maysoun Dimachkie Masri, University of Central Florida, Corresponding Author

Bernardo Ramirez, University of Central Florida
Cristina Popescu, University of Central Florida
Ed Michael Reggie, Tulane University

Purpose

U.S. pharmaceutical companies outsource research activities to contract research organizations

(CROs) to increase their profit margins and better position themselves in the rapidly-changing

healthcare environment. In this article, the authors explore the evolution of the CRO industry in

the United States and worldwide, and discuss the benefits and pitfalls of CRO globalization in

recent years.

Design/methodology approach

The organizational ecology framework is used to analyze the CROs emergence, growth, and

evolution to date, in response to environmental changes. Organizational ecology is the study of

dynamic changes within a given set of organizations. Most organizations have structural inertia

that hinders adaptation when the environment changes. Those organizations that become

incompatible with the environment are eventually replaced through competition with new

organizations better suited to external demands

Findings

In recent years, there has been a clear shift toward globalization of clinical trials, as a result of

the economic downturn, tighter control in the US and less stringent regulations abroad, in

addition to a quest to increase efficiency, cost savings, and greater access to diverse study

populations. The areas in most demand to conduct clinical trials in are India, China, and Central

2
and Eastern Europe. Conducting clinical trials in developing countries can be beneficial in that it

could stimulate research collaborations and could introduce new drugs throughout the world. At

the same time, there is concern about the accuracy and quality of clinical trial data, as well as the

ethical treatment and safety of research participants in the absence of strict research monitoring.

A multi-level approach could be used to address these concerns.

Originality/value

This article gives a contemporary overview of the CRO industry. The authors explain its current

state within an organizational change framework. The activities of CROs in the United States are

compared and contrasted to those in emerging markets. The implications of research outsourcing

and CRO globalization are discussed.

Keywords: Contract Research Organizations, CROs, CRO General Review, CRO Globalization,

Drug Development, FDA, CRO Market Analysis

3
 Contract Research Organizations: An Industry Analysis

Introduction

A number of factors create a high demand for clinical trials in the United States. Some of these

factors are the aging of the population, the high prevalence of chronic diseases, the embrace by

physicians and payers of evidence-based medicine, and the patients common belief that they

will benefit from new medical technologies and treatments. Patients volunteer into clinical trials

to gain early access to medication, treatments, and medical care. A large number of Americans

(70%-83%) believe that clinical research is very important or essential to advancing public

health (Research America, 2009). However, only a minority of Americans (31%) believes that

the United States Food and Drug Administration (FDA) has been effective at ensuring public and

patient safety (Harris Interactive, 2007), despite FDAs mission to promote and protect public

health by approving safe and effective drugs.

Several challenges have faced the drug industry: rising drug costs, differences in cost

between drugs in the United States and in other developed countries such as Canada and the

United Kingdom, and long marketing time. Furthermore, the safety of drug development has

been called into question and public trust in the industry has declined (Glickman et al., 2009;

Shtilman, 2009).

In recent years, the drug industry has had to change the way drugs are developed in order

to ensure better patient safety. The quest for reliable endpoints in research has led to a large

number of trials. As of October 2011, more than 114,000 clinical trials were being conducted in

the U.S. and other 177 countries (National Institutes of Health, 2011). An estimated 900 new

drugs and vaccines targeting 100 diseases are in development in the U.S., either in clinical trials

or under FDA review (PhRMA, 2011).

4
 Clinical trials have shifted from academic medical centers to community-based practices

(Robuck and Wurzelmann, 2005; Scott, 2003). Community-based sites could be a single

community hospital or physician groups (solo practice, small group, medium site group, large

single specialty, or multi-specialty group). In addition, greater FDA scrutiny, complicated

logistics, and requirements for more data have helped the growth in professional research sites.

Currently, pharmaceutical and biotechnology companies increasingly use contract research

organizations (CROs) to complete drug research projects faster and at a lower cost. The CRO

market size was estimated at $24 billion in 2010 and increasing by approximately 15%, despite

the fact that major CROs have seen their profits fall by 50% compared to previous years

(Biopharm Knowledge Publishing, 2011).

This article uses the organizational ecology framework (Hannan and Freeman, 1977;

Ivery, 2007) to analyze the lifecycle of CROs in response to their environment: their birth,

growth, and evolution up to the current stage. The paper will first discuss the drug development

process, the role of CROs, and outsourcing in clinical research. Second, the paper will include an

analysis of the CRO industry, how it evolved over time, the different factors affecting it, the

current globalization stage, and the positive and negative consequences of globalization.

Subsequent articles by the same authors will analyze the effects of research outsourcing on the

cost and quality of clinical trials conducted by CROs and the use of CROs by nonprofit and for-

profit U.S. community-based hospitals.

Drug development process

It is essential to understand the long and complex drug development process in the U.S. before

analyzing the role of CROs. In 1938 the Food, Drug, and Cosmetic Act was passed to ensure that

5
every new drug is approved by the United States Food and Drug Administration (FDA) before it

is available on the market. The drug development process is induced by both a medical need and

a business opportunity. The pharmaceutical industry invests as much as five times more than the

average manufacturing company in research and development relative to their sales

(Congressional Budget Office, 2006). Globally, the U.S. represents the largest market for

pharmaceuticals, accounting for approximately $190.4 billion in 2005 compared to $57.5 billion

in Japan (Matrix 2.0, 2006). Creating a new drug is both time consuming and expensive. In 2005,

the average cost of developing drugs was estimated at $1.3 billion (DiMasi and Grabowski,

2007).

Drug research and development process

The research and development (R&D) process of every new drug is complex and lengthy. There

are four stages in the process: drug discovery, preclinical research, clinical trials, and FDA

review. The time span between the drug discovery phase and the FDA approval can take up to 15

years (PhRMA, 2011b). On average, for every product that will eventually reach the market,

10,000 compounds are screened during the discovery stage. During this stage, drugs are studied

in-vitro and, if possible, in animal models of disease. Approximately 250 compounds make it

into stage 2 of drug development, known as preclinical research, where pharmacology and

toxicology studies are conducted. If the results in stage 2 look promising, the manufacturer

submits an Investigational New Drug (IND) application to the FDA for review. If the application

is approved, the manufacturer may proceed with clinical testing (stage 3) in humans. About five

compounds are approved for stage 3 clinical trials, during which they are tested on volunteer

participants in three phases. This stage can take up to seven years to complete (PhRMA, 2011b).

6
Types of clinical trials (stage 3)

The aim of phase I of clinical trials is to establish the safety and pharmacology of the drug.

Phase I is conducted with 20 to 80 healthy volunteers who are closely monitored in an in-patient

setting. This trial period may take up to two years.

In phase II of clinical trials, research focuses on pharmacokinetics, bioavailability, drug-

disease, and drug-drug interactions. The intent is to test the effectiveness of drugs on specific

populations and for specific diseases. This phase may involve between 100-500 subjects over

longer treatment intervals (between six and 12 weeks).

The main aim behind phase III of clinical trials is to confirm the safety and efficacy of

the drug under study. The experimental drug or treatment is given to large groups of volunteer

subjects (between 1,000-5,000 participants) in the U.S. and other countries. The FDA requires at

least two adequate and well-controlled studies for approval (PhRMA, 2011a; PhRMA, 2011b).

FDA review

Once phase III of the clinical trials is completed successfully, the manufacturing company files a

New Drug Application (NDA) with the FDA. This application includes all the drug-related

information collected in the previous steps. The review takes place in stage 4 of the drug

development process and may take up to two years. A drug may get an S for standard review if

it is similar to other drugs currently available, or a P for priority review if the drug represents a

significant advance over existing products. All drugs must be approved by the FDA before they

could be marketed to consumers (Madden, 2005).

The FDA could approve drugs conditionally and request the manufacturer to continue to

perform further studies. Those extended studies are called phase IV or commitment studies.

Phase IV studies are used to confirm the drugs safety and efficacy, as well as to test for side

7
effects and additional benefits. In theory, failure to complete such studies should result in the

drug's withdrawal from the U.S. market. However, according to the FDAs 2005 report on

performance of the commitment studies, of 1,191 open post-marketing commitment studies, only

114 had been conducted (Madden, 2005). Daniel Klein and Alexander Tabarrok argue that FDA

control over drugs and devices has often overlooked costs that almost certainly exceed the

benefits (Madden, 2005). They believe the FDA regulation of the medical industry has

suppressed and delayed new drugs and devices. Furthermore, the FDAs review process has

increased costs, with a net result of more morbidity and mortality.

Outsourcing in clinical research

Large pharmaceutical companies increasingly are using downsizing strategies to be able to

concentrate their resources on core skills and specialties. Pharmaceutical companies are

outsourcing aspects of their drug development, manufacturing, and marketing processes. There

are several reasons behind this outsourcing process, some of which include lack of in-house

capacity, skill deficiency, and cost control. For example, specific services may be unavailable in

a pharmaceutical company. The company may need special regulatory expertise to operate in a

foreign country, or the company may want to reduce its fixed cost and turn part of it into variable

cost. However, one of the main reasons for outsourcing is the downward cost pressures exerted

on pharmaceutical manufacturers profit margins. Given that these cost pressures may continue

to increase in the future, contract research organizations (CROs) are becoming more of an

important strategic partner for pharmaceutical companies.

8
CROs role

According to the Code of Federal Regulations, the U.S. FDA regulations state that a CRO is "a

person that assumes, as an independent contractor with the sponsor, one or more of the

obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations,

evaluation of reports, and preparation of materials to be submitted to the Food and Drug

Administration" (US Food and Drug Administration, 2011).

When CROs were first created, they offered pharmaceutical companies a limited number

of research services. Outsourcing activities included either biostatistician consulting or clinical

research associate (person responsible for monitoring investigational sites for regulatory

compliance) support (Beach, 2001). All those activities were moderately specialized. At present,

full-service CROs offer a broader range of services including the selection of investigators and

investigational sites, assistance with patient recruitment, safety surveillance and reporting, site

audits, and clinical trials data management and biostatistics (Getz and Vogel, 2009; Shtilman,

2009).

Organizational ecology theory and CROs

Organizational ecology is the study of dynamic changes within a given set of organizations. It

examines the birth and mortality of organizations and organizational forms within the population

over long periods. Most organizations have structural inertia that hinders adaptation when the

environment changes. Those organizations that become incompatible with the environment are

eventually replaced through competition with new organizations better suited to external

demands (Hannan and Freeman, 1977; Ivery, 2007). T.Y. Lee, Vice President of Clinical

Development and Asia Venture of Kendle International stated, The traditional nature of CROs

has changed and they will evolve into a formidable industry (Lee, 1998). Based on the

9
organizational ecology theory, the following section of this article discusses the evolution of

CROs over time.

Birth period

Pharmaceutical companies faced a number of pressures between 1970 and early 1990s. The

R&D cost was doubling every five years. The average cost of bringing a drug to market grew

from $125 million in 1989 to $231 million in 1993 (Brooks, 2006). Although prescription drug

prices continued to rise, the probability of developing a successful drug was very small. In

addition, the R&D costs increased faster than drug prices. Furthermore, biotech companies were

faced with decreasing available capital. The industrys stock value fell 6%, while the R&D rose

about 14% (Brooks, 2006). Several important changes occurred: downsizing of pharmaceutical

companies, out-licensing non major products, and a number of mergers and consolidations (Lee,

1998). Other pharmaceutical companies developed the over-the-counter market and some simply

gave up research and clinical trials.

As a result of these changes, CROs were born to fill a demand for innovative

organizations whose routines and competencies vary from the pharmaceutical companies. CROs

were successful in reproducing themselves and giving rise to a new population of organizations.

Growth period

The CRO population gradually increased. In 2004, top CROs managed about 23,000 phase I

through phase IV trials worldwide, monitored more than 150,000 clinical investigators, and

enrolled more than 640,000 new subjects (Brooks, 2006). The main reason behind this growth is

CROs specialization and the creation of niche CRO service providers. Today, the industry is

evolving more toward a full-service model, with CROs offering services from the earliest stages

10
of development through clinical trials and post-approval research. CenterWatch surveys of major

pharmaceutical companies revealed that sponsor outsourcing activities have changed in recent

years (CenterWatch, 2009). Sponsors are not increasing the overall level of CRO involvement in

their clinical projects; instead, they are using CROs for a variety of clinical activities.

CROs in North America offer a wide range of services, as illustrated in Figure 1. As of

2006, most services were being offered in phase II through phase IV trials, followed by Dealer

Management Systems (DMS), and regulatory affairs.

Figure 1

Services Offered by CROs in North America (2006)

Preclinical/Toxicology

Lab Analysis

QA

Phase I

Regulatory Affairs

DMS

Phase II-IV

0 50 100 150 200 250 300

Source: Biopharm Knowledge Publishing, The Contract Research Annual Review 2006

Because CROs are evolving toward full-service companies, they are increasingly

assuming the regulatory and ethical risks and responsibilities inherent in the conduct of clinical

trials. In this full-service role, CROs, unlike sponsors, have no vested interest in the outcome of

the study. However, like sponsors, they are subject to heavy regulation by the federal

11
government (Glickman et al., 2009; Shtilman, 2009). CROs must follow state laws and

international guidelines, as well as their own operating procedures. CROs are also subject to

comprehensive audits by the FDA and the sponsoring companies.

Current period

CROs pursue different strategies to overcome the pressures discussed above. Full-service CROs

are getting competition from nimble niche and midsize players. To overcome the competition,

those organizations tend to operate like their focused and niche-oriented clinical service

counterparts. As for the mid-sized, small, and niche CROs, their aim is to maintain growth. Thus,

these organizations mainly focus on those services that have secured their relationships with

sponsors. One could call this phase a renaissance of the CRO market, in which study sponsors

are increasingly dependent upon research outsourcing.

CRO globalization and emerging markets

The pharmaceutical industry has been increasingly challenged to expedite the drug development

process and to make it more efficient. Competition, poor economic conditions, downsizing,

increased government scrutiny, and pricing pressure from healthcare organizations have lead

pharmaceutical companies to find ways to reduce the costs of production and manufacturing

(Gad and Spainhour, 2011).

Most pharmaceutical research has traditionally been conducted in affluent regions such as

North America, Western Europe, and Australia; these three regions in 2007 held 66% of the

clinical trial market share, with the U.S. hosting 49% of trial sites. However, other regions have

emerged in recent years (Thiers et al., 2008). Reasons for this globalization trend have included:

12
reduced operational costs; ability to recruit more diverse research participants in a shorter

amount of time; easier regulatory processes abroad; faster protocol approval; and availability of

highly skilled professionals in emerging research markets (Clemens, 2010; Singh, 2008; Thiers

et al., 2008).

This influx and geographical spread of U.S.-sponsored clinical trials is being summarized

in a data registry, Clinicaltrials.gov, which includes detailed information about completed and

ongoing trials in 177 countries. Figure 2 indicates the number of clinical trials (all phases) being

conducted in different regions of the world by US companies and registered with the National

Institutes of Health as of October 2011 (US National Institutes of Health, 2011).

FIGURE 2

Number of Clinical Trials by World Regions (2011)

Central America

Africa

Pacifica

South America

Middle East

Asia

Europe

North America

Worldwide

0 20,000 40,000 60,000 80,000 100,000 120,000

Source: US National Institutes of Health, ClinicalTrials.gov registry (2011)

13
 Table 1 displays the countries where most trials documented in the registry are being

conducted (US National Institutes of Health, 2011).

TABLE 1

Number of Clinical Trials by Country (2011)

Country Number of Clinical Trials

United States 56,981

Canada 8,745

Germany 8,002

France 6,820

United Kingdom 5,867

Italy 4,461

Spain 3,920

Netherlands 3,635

Belgium 3,378

Israel 3,190

Australia 3,049

South Korea 2,800

Denmark 2,799

China 2,460

Brazil 2,448

Poland 2,405

Switzerland 2,376

Taiwan 2,341

Sweden 2,320

Austria 2,125

Japan 2,014

Source: US National Institutes of Health, ClinicalTrials.gov registry (2011). Only countries conducting 2,000 or
more clinical trials were included in the table.

14
 Operating in different countries poses problems to the CROs, as well as to the sponsoring

companies, because they are subject to different guidelines and regulations, both national and

international (Premkumar et al., 2010). To address some of the problems, the Global CRO

Council for Bioanalysis was created by 34 CROs in 2010 (Global CRO Council, n.d.).

The outsourcing of clinical trials to developing countries has not been without

controversy. Proponents discuss the financial benefits brought to the country, as well as the

medical care that study volunteers receive at no expense to them. Critics, however, point out that

the research subjects typically lack health insurance and financial means to receive medical care

on their own. Therefore, economic reasons are forcing them to become test subjects, though

sometimes they are not informed they are being tested and being administered drugs that have

not yet been approved (Clemens, 2010; Drabu et al., 2010; Singh, 2008). Some credibility

concerns should be alleviated by CROs joining international regulatory bodies. For example,

numerous CROs have been found in compliance with Good Laboratory Practices (GLP)

developed by the Organization for Economic Cooperation and Development (OECD) (Gad and

Spainhour, 2011).

In recent years, three regions have emerged as hot up-and-coming CRO markets: India,

China, and Central and Eastern Europe. The following paragraphs discuss the rise of these new

CRO markets and their advantages over traditional clinical research sites.

CROs in India

For Pai et al.(2009), it is the six senses that are the driving forces behind Indias emergence as

a CRO market: patient recruitment rates, quality of services, reasonable cost-quality ratio,

existence of regulatory agencies, high standards of care, and English-speaking skills. The FDA

15
has even opened a regional office there, as a result of the volume of data generated in clinical

trials (Pai et al., 2009). International companies are entering the healthcare sector and creating

their own niches (Drabu et al., 2010). The cost of conducting clinical trials in India is estimated

to be 50%-60% lower than in the United States or the European Union (Bhowmik et al., 2010).

Estimates put Indias CRO market at $35 billion by 2013 (Drabu et al., 2010). Local

market regulations continue to make India more and more appealing to pharmaceutical

companies. The Indian customs department has eliminated import taxes for investigational drugs

(Pai et al., 2009). All Indian clinical trials must be registered in the Clinical Trials Registry -

India before volunteer enrollment can proceed (Drabu et al., 2010).

In spite of Indias increased visibility in the CRO market, the economic downturn has

taken a toll. Some CROs have ceased operations (particularly those with a few clients and a few

projects), while others continue to expand. One Indian CRO executive saw the recession in the

U.S. as an opportunity to attract and hire Indian-born, U.S.-educated physicians and scientists

(Jayaraman, 2009).

Some are beginning to wonder whether Indias CRO potential has really lived up to the

hype (Redfearn, 2011). The number of clinical trials outsourced to India has been declining

recently and commentators see several possible explanations: the Western pharmaceutical

industry entered the Indian market too quickly, too soon, without plans for long-term

investments; Western companies one size fits all approach to research does not work in India;

CROs started charging study sponsors Western prices, despite the Indian market being much less

expensive; bureaucratic regulatory process and random policies imposed on CROs (Redfearn,

2011).

16
CROs in China

Chinas CRO market developed in the early 2000s, after the country joined the World Trade

Organization and developed regulations for the drug industry. Novo Nordisk set up an R&D

center there in 2002 and other large U.S. pharmaceutical companies followed in subsequent

years. It is estimated that China will soon be the second largest Asian pharmaceutical market

after Japan (Gambrill, 2010). CRO revenues in China are forecast to reach $240 million by 2012

(Gad and Spainhour, 2011). Although there has been some suspicion over the quality and

validity of clinical trials conducted by Chinese CROs, there does not appear to be any convincing

evidence to prove wrongdoing (Gad and Spainhour, 2011). As with India, the FDA now has

permanent offices in China.

Some downsides to conducting clinical trials in China are said to include: slow

turnaround, language barriers, and government interference in the regulatory process. One senior

director at a U.S. pharmaceutical company thinks, [P]eople are taking a wait-and-see approach

to China. Theres a fear of getting it wrong. People are instead working to understand the

marketplace, the legal infrastructure, the IP rights (Redfearn, 2011, p. 22).

CROs in Central and Eastern Europe

A different picture emerges from Europe. More than one in four clinical trials documented in

NIHs registry is being conducted in Europe (US National Institutes of Health, 2011). CRO

revenues are forecast to increase to $7.6 billion in 2012 (Newman, 2010). There has been an

increase in the number of niche CROs in regulatory, pharmacovigilance, and clinical drug supply,

while other large CROs are struggling.

17
 Europe is a desirable market for pharmaceutical companies to conduct trials, particularly

phase I, for different reasons than emerging countries: highly qualified staff, fluency in foreign

languages, quality of services and infrastructure, size of the continent, and ability to handle

multi-country trials (Newman, 2010; Shtilman, 2009). The main deterrent, however, is the cost

of conducting the trials. In fact, the overall costs in the European Union (including taxes, salaries,

overhead, etc.) are said to be higher than those in the U.S. (Newman, 2010). One way European

CROs are coping with the difficult economic situation worldwide is by developing strategic

alliances and expanding to cheaper, less saturated markets in Eastern Europe (Newman, 2010).

The former Soviet Union countries are particularly appealing to large pharmaceutical

companies for some of the reasons mentioned above (Shtilman, 2009). However, the expansion

of clinical trials in that area has also led to ethical concerns for the safety and protection of

research subjects. The FDA, although it oversees all clinical research conducted by U.S.

companies and their CROs, has effective jurisdiction only when trials are conducted in the

United States. FDA regulations can be circumvented in clinical trials conducted in other

countries. Moreover, the governments and regulatory agencies in those countries do not have the

knowledge or the capacity to regulate clinical trials and to ensure the safety and ethical treatment

of volunteer subjects.

Conclusion

This article used the organizational ecology framework to analyze the lifecycle of CROs: their

birth, growth, evolution, and current stage. The paper discussed the drug development process,

the role of CROs, outsourcing in clinical research, and the state of the CRO industry. In recent

years, there has been a clear shift toward globalization of clinical trials, as a result of the

18
economic downturn, tighter control in the US and less stringent regulations abroad, and in a

quest for more efficiency, cost savings, and greater access to diverse study populations

(Glickman et al., 2009).

The article has identified some of the positive and negative consequences of globalization.

Conducting clinical trials in developing countries can be beneficial in that it could stimulate

research collaborations and could introduce new drugs throughout the world. At the same time,

there is concern about the accuracy and quality of clinical trial data, as well as the ethical

treatment and safety of research participants in the absence of strict research monitoring

(Glickman et al., 2009; Shtilman, 2009). It has been suggested that multiple approaches are

needed to alleviate these concerns. The approaches could involve policy changes in the countries

where clinical trials are conducted; tighter control and authority to enforce research regulations;

mandating the use of Institutional Review Boards (IRBs); conducting research to address local

societal needs rather than one companys interest; transparency in the conduct of research and

the results obtained; education of volunteer participants about the research process and its

possible consequences (Glickman et al., 2009).

As clinical trials and research outsourcing continue to expand to less developed countries,

more challenges are likely to come up. Subsequent articles by these authors will focus on the

effects of research outsourcing on the quality and the cost of clinical trials conducted by CROs.

19
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Authors Biographical Details

Maysoun Dimachkie Masri, Sc.D., is an Assistant Professor in the Department of Health

Management and Informatics at the University of Central Florida. Dr. Dimachkie Masri received
her Doctorate of Science from Tulane University. Her teaching interests include finance,
financial decision making and management, economics, and managed care. Her research
interests include the evolution of Accountable Healthcare Organizations (ACOs) as a new
healthcare financing mechanism, the growth in retail clinics and contract research organizations,
and physician supply and demand needs.

Bernardo Ramirez, M.D., M.B.A., is an Assistant Professor, Director of the Undergraduate HSA
program, and Director of Global Health Initiatives in the Department of Health Management and
Informatics at the University of Central Florida. Dr. Ramirez has been General Director of
Health Standards of the Ministry of Health of Mexico, Vice-President and Director of
International Programs of the Association of University Programs in Health Administration
(AUPHA). He has been a senior instructor for the Center for Creative Leadership-TEAM, and
senior consultant for the Academy of Educational Development, the American International
Health Alliance and other organizations worldwide. He has provided technical assistance,
developed research, conducted training, and presented in more than 50 countries on topics such
as: health management training and development, quality improvement, performance assessment,
strategic and change management, leadership, health systems reform, and sustainability. Dr.
Ramirez is a member of the AUPHA Board of Directors, the Florida Hospital SHARES
International Board, and several advisory and editorial boards.

Cristina Popescu is a doctoral student in the Public Affairs program (Health Services
Management and Research track) at the University of Central Florida. Popescu holds a masters
degree from the University of Florida, where she has worked as manager and coordinator of
several research projects, contracts, and grants for local and state agencies.

Ed Michael Reggie, M.B.A., is the Chairman of the Board of GuideStar Clinical Trials
Management, a Chicago-based company that provides comprehensive, outsourced clinical trials
management services to medical facilities and physician practices across the country. In addition,
he serves on the Board of the New Orleans BioInnovation Center, a wet lab incubator and a
Good Manufacturing Practices laboratory for stem cell, vector and DNA production. Reggie
founded American LIFECARE, a multi-state managed care organization, now a portfolio
company of The Carlyle Group. Previously, he served as the Chief Executive Officer of Regent
Health System, a rural hospital chain. He was a founding member of the Louisiana Health Care
Commission. In 2010, Reggie was a recipient of the Champion of Public Health award for his
efforts as Chairman of the "Biology to Business" conference.

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